510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192117Small VBR™Ulrich GmbH & Co. KG20196—
+6K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K162262Tritanium® PL CageStryker2016132—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K161369EVEREST Spinal SystemK2m, Incorporated20169—
+6K160955Tritanium® PL CageStryker2016178—
+6K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+6K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+6K152651AccuLIF TL and PL CageStryker Corporation201530—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+6K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K171321K2M Navigation InstrumentsK2m201711
+7K171425Concorde LiftMedos International SARL201782
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—